Clinical Research Directory
Browse clinical research sites, groups, and studies.
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
Sponsor: University of Arkansas
Summary
The goal of this randomized controlled trial was to determine the effectiveness of a Healthy Food Delivery Intervention (HFDI) on the outcomes of rural food insecure patients with type 2 diabetes mellitus (T2DM). Our specific aims were to: 1. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diabetes-related outcomes among rural food insecure patients with T2DM. Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved: H1- glycemic control as measured by HbA1c; H2- cardio-metabolic risk factors: body mass index (BMI), blood pressure, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, blood glucose; H3- diabetes management self-efficacy; H4- diabetes-related distress. 2. Compare the effectiveness of the HFDI and CDCES Consultation Only to improve diet quality among rural food insecure patients with T2DM. Hypotheses: Compared with CDCES Consultation Only, patients receiving the HFDI will demonstrate improved: H1- Healthy Eating Index 2015 (HEI-2015) scores; H2- fruit and vegetable consumption as measured by Veggie Meter scores. 3. Compare cost-effectiveness to understand HFDI costs in relationship to outcomes in relation to CDCES Consultation Only. Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
416
Start Date
2021-10-22
Completion Date
2025-12-18
Last Updated
2026-09-16
Healthy Volunteers
Yes
Conditions
Interventions
Healthy Food Delivery Intervention
Participants randomized to the Healthy Food Delivery Intervention receive standard of care, a CDCES Consultation, food pantry resource guide, and weekly home delivery of type 2 diabetes-appropriate food boxes over 3 months (12 food boxes in total).Each food box included approximately 9000 calories of food. Food boxes were designed by a Registered Dietician. Food boxes also included recipes and cooking tips specific to foods included in that week's box.
CDCES Consultation Only
Participants randomized to this study arm receive the standard of care at the clinic from which they were recruited, plus a 60 minute healthy eating consultation with a Certified Diabetes Care and Education Specialist and a food pantry resource guide specific to their community.
Locations (13)
UAMS - North Central
Batesville, Arkansas, United States
Pocahontas Medical Center
Corning, Arkansas, United States
Washington Regional Medical Center
Eureka Springs, Arkansas, United States
UAMS - Northwest
Fayetteville, Arkansas, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
UAMS - West
Fort Smith, Arkansas, United States
Washington Regional Medical Center
Harrison, Arkansas, United States
UAMS - East
Helena, Arkansas, United States
UAMS - Northeast
Jonesboro, Arkansas, United States
UAMS - South
Magnolia, Arkansas, United States
Lee County Cooperative Clinic
Marianna, Arkansas, United States
Boston Mountain Rural Health Center
Marshall, Arkansas, United States
Pocahontas Medical Clinic
Pocahontas, Arkansas, United States